saturn project - innovheart...feb 26, 2018 · saturn technology: think mitral! 6 safe to the...

SATURN PROJECT:

a solid approach toMV transcatheter replacement

Paolo Denti MD

San Raffaele Hospital

Milan, Italy

Potential conflicts of interest

Paolo Denti is:

▪ Consultant for Valtech Cardio, Abbott, 4tech Cardio and InnovHeart

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Native mitral leaflets are entrapped between the valve and

the annular components

• An annular structure is positioned behindthe leaflets, in contact with the annulus.

• The valved central element is expandedinside the mitral orifice, to lock the nativeleaflets in between.

Annular Structure

Self Expandable Valve

Saturn Technology: think mitral!

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Because of the need of appropriate anchorage and appropriate seal

from a “two components system” to a “single piece / multifunctional parts”


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ANNULAR STRUCTURE2 separable segments to embrace the mitral leaflets

CENTRAL ELEMENTsupporting prosthetic leaflets

CONNECTING ARMSon both sides of the central element

CONNECTING MECHANISMon each connecting arm

CONNECTING MECHANISMSsuitable for intracardiac reassembling of the prosthesissuitable for intracardiac reassembling of the prosthesis

before final release

Saturn Design – single piece / multifunctional parts


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Safe to the Target: based on Guidewires

Implant procedure (including intra-cardiac reassembling) is led by GuideWires

connecting arms and annular segments are compatible with over-the-wire technics


Saturn Technology: TA - Implant Procedure

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Three Steps Procedure

1) Placement of a pair of guidewires to embrace the native mitral valve

2) Over the wire introduction and positioning of the annular segments

3) Introduction of the central valve body, intracardiac reassembling and release

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• Transapical procedure already validated in chronic animal models

• GLP in-vivo preclinical trial start Q1-2018

ventricular view of explanted pig heart

pig heart sheep heart

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STEP 1Placement of a pair of guidewires to embrace the native mitral valve

Saturn Technology: TS Implant Procedure

Trans-femoral trans-septal procedure under development

STEP 2Over the wire introduction and positioning of the annular segments

Saturn Technology: Strengths

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PATIENTS SCREENINIG: TWO MAJOR LIMITING FACTORS

Native Annulus Size Risk of LVOT Obstruction(direct and SAM)


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• Inverse Remodeling of the Mitral Annulus

Size reduction – Annuloplasty-like

Additional benefits from small size prostheses

✓ BETTER CRIMPABILITY

lower profile delivery systems

✓ LONGER DURABILITY

less stress on the prosthesis (applied forceincreases with the square of the diameter)

An Effective Solution to address Native Annulus Size Challenge


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• Inverse Remodeling of the Mitral Annulus

Size reduction – Annuloplasty-like

• Stabilization of the Mitral Annulus

Surgical-like anchoring to the annulus

An Effective Solution to address Native Annulus Size Challenge


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An Effective Solution to address Risk of LVOT Obstruction

Left Ventricular

Side

Left Atrial Side

• Low Profile Prosthesis

Reduced risk of LVOT


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An Effective Solution to address Risk of LVOT Obstruction

• Low Profile Prosthesis

Reduced risk of LVOTO

• Anterior Leaflet gripped by Connecting Arm

Reduced risk of SAM

Saturn Technology: Think Mitral!

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• Simple and accurate implant, based on daily used cathlab GuideWires

• Surgical-like anchoring to the mitral annulus, structure stabilization

• Annular size reduction, immediate remodeling

• Low profile prosthesis, low LVOT Obstruction risk

• No SAM risk

saturn project - innovheart...feb 26, 2018 · saturn technology: think mitral! 6 safe to the...

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